Regulatory affairs

Herein, a modern method is proposed for exchanging and processing real-time medicinal product information using Health Level 7 International's (HL7) Fast Healthcare Interoperability Resources (FHIR®) standard, Application Programming Interfaces (API), digitization and artificial intelligence. FHIR is presently in use largely to facilitate interactions between patient-facing healthcare institutions, such as hospitals, doctor's offices, and laboratories, for electronic health record management and exchange...

The purpose of this article is to propose and provide a blueprint for a graduate-level curriculum in clinical data science, devoted to the measurement, acquisition, care, treatment, and inferencing of clinical research data. The curriculum presented here contains a series of five required core courses, five required research courses, and a list of potential electives. The coursework draws from but does not duplicate content from the foundational areas of biostatistics, clinical medicine, biomedical informatics, and regulatory affairs, and may be reproduced by any institution interested in and capable of offering such a program...

The tumor microenvironment corresponds to a complex mixture of bioactive products released by local and recruited cells whose normal functions have been "corrupted" by cues originating from the tumor, mostly to favor cancer growth, dissemination and resistance to therapies. While the immune and the mesenchymal cellular components of the tumor microenvironment in colon cancers have been under intense scrutiny over the last two decades, the influence of the resident neural cells of the gut on colon carcinogenesis has only very recently begun to draw attention...

Most major insurers operate in both the commercial health insurance and Medicare Advantage (MA) markets. We investigated the ratio of commercial-to-MA prices negotiated by the same insurer, in the same hospital and for the same services, using 2022 price information disclosed by hospitals in compliance with the hospital price transparency rule. Insurers negotiated median hospital prices for commercial plans that were two to three times higher than their MA prices in the same hospital for the same service. The median commercial-to-MA price ratio in the same hospital varied, from 1...

Due to rapid development of biotechnology in recent years, the field of regenerative medicine has attracted considerable attention. Regenerative medicine-related regulations have been established in several countries to ensure the quality, safety, and efficacy of innovative treatments. Considering the diversity of regenerative medicine, the regulatory framework in Taiwan has been adjusted in response to global trend and local demand. Before 2010, cell and gene therapies were regarded as "new medical practice" under the "Medical Care Act...

The development and production of cell gene and tissue (CGT)-based therapies requires a specialized workforce. Entering the CGT arena is complex because it involves different scientific and biomedical aspects (e.g., immunology, stem cell biology and transplantation), as well as knowledge of regulatory affairs and compliance with pharmaceutical quality standards. Currently, both industry and academia are facing a worldwide workforce shortage, whereas only a handful of educational and training initiatives specifically address the peculiarities of CGT product development, the procurement of substances of human origin, the manufacturing process itself and clinical monitoring and biovigilance...

The mutating SARS-CoV-2 necessitates gauging the role of airborne particulate matter in the COVID-19 outbreak for designing area-specific regulation modalities based on the environmental state-of-affair. To scheme the protocols, the hotspots of air pollutants such as PM2.5 , PM10 , NH3 , NO, NO2 , SO2 , and and environmental factors including relative humidity (RH), and temperature, along with COVID-19 cases and mortality from January 2020 till December 2020 from 29 different ground monitoring stations spanning Delhi, are mapped...

OBJECTIVES: Opioid use is associated with fall-related injuries (FRI) among older adults, especially those with dementia. We examined FRI following changes in national opioid safety initiatives over 3 regulatory periods [preinitiatives baseline (period 1): October 2012 to June 2013; post-Veteran Affairs (VA) opioid safety initiative (period 2): January 2014 to November 2015; post-VA and CDC opioid prescribing guidelines (period 3): March 2017 to September 2018] among Department of VA Community Living Center (CLC) long-stay residents with dementia...

Chemical flow analysis (CFA) can be used for collecting life-cycle inventory (LCI), estimating environmental releases, and identifying potential exposure scenarios for chemicals of concern at the end-of-life (EoL) stage. Nonetheless, the demand for comprehensive data and the epistemic uncertainties about the pathway taken by the chemical flows make CFA, LCI, and exposure assessment time-consuming and challenging tasks. Due to the continuous growth of computer power and the appearance of more robust algorithms, data-driven modelling represents an attractive tool for streamlining these tasks...

Nutraceuticals are gaining importance owing to the current pandemic situation and increasing focus on overall health. Nutraceuticals include products, which help in maintaining immunity and prevent diseases. It also includes products that support the optimal functioning of the human body. Poor nutrition plays an important role in lifestyle-related disorders as well. Various nutraceuticals have exhibited therapeutic potential, hence gaining popularity. Nutraceuticals are mainly categorized into dietary supplements and functional foods...

Artificial intelligence (AI) refers to the ability of a computer to carry out tasks associated with human intelligence, including thinking, discovering, and learning from prior experience. AI can be integrated to simplify the complexity of pharmaceutical regulatory affairs. AI tools can be applied to automate regulatory processes such as administrative work, dossier filling, data extraction, auditing, the implementation of regulations, and quality management. AI creates process links and reduces complexity, resulting in a more efficient management system...

The role and value of statistical contributions in drug development up to the point of health authority approval are well understood. But health authority approval is only a true 'win' if the evidence enables access and adoption into clinical practice. In today's complex and evolving healthcare environment, there is additional strategic evidence generation, communication, and decision support that can benefit from statistical contributions. In this article, we describe the history of medical affairs in the context of drug development, the factors driving post-approval evidence generation needs, and the opportunities for statisticians to optimize evidence generation for stakeholders beyond health authorities in order to ensure that new medicines reach appropriate patients...

BACKGROUND: Insights, when acted upon, can result in positive changes to the business, for HCPs, and ultimately for patients. Medical Information, as a customer facing function, is one of the groups that generate insights. Data and insights across different functions of an organization need to be compiled to provide a comprehensive view. The purpose of this paper is to develop a shared definition of insights and to provide a working guidance for the insight process. METHODS: Two surveys were conducted of the phactMI membership first to establish a shared definition of insights and then to benchmark current insight process...

In the USA, the Food and Drug Administration plans to regulate artificial intelligence and machine learning software systems as medical devices to improve the quality, consistency, and transparency of their performance across specific age, racial, and ethnic groups. Embryology procedures do not fall under the federal regulation of "CLIA 88." They are not tests per se; they are cell-based procedures. Likewise, many add-on procedures related to embryology, such as preimplantation genetic testing, are considered "laboratory-developed tests" and are not subject to Food and Drug Administration regulation at present...

PURPOSE: The introduction of artificial intelligence / machine learning (AI/ML) products to the regulated fields of pharmaceutical research and development (R&D) and drug manufacture, and medical devices (MD) and in vitro diagnostics (IVD), poses new regulatory problems: a lack of a common terminology and understanding leads to confusion, delays and product failures. Validation as a key step in product development, common to each of these sectors including computerized systems and AI/ML development, offers an opportune point of comparison for aligning people and processes for cross-sectoral product development...

Julie G Allickson, PhD, is the Michael S and Mary Sue Shannon Family Director of Mayo Clinic's Center for Regenerative Biotherapeutics at Mayo Clinic (Minnesota, Florida and Arizona) and the Otto Bremer Trust Director, Biomanufacturing and Product Development, Center for Regenerative Biotherapeutics. With over 25 years of experience in regenerative medicine, cellular therapies and regulatory affairs, Dr Allickson leads the center as it pivots toward biomanufacturing, ensuring that discoveries are successful for clinical translation and eventually commercialization...

In the US in recent years, hospital-physician integration has become a dominant form of consolidation in health care. This transition away from independent practice has raised questions about whether hospital-employed physicians may be more likely than independent physicians to refer patients to high-intensity, hospital-based services. We used Medicare claims data from the period 2013-20 to identify patients who received a new diagnosis of stable angina, a common cardiovascular condition that entails clinical discretion in treatment choice...

A method based on micellar liquid chromatography has been developed to determine rosuvastatin, lovastatin and simvastatin in oral solid dosage forms. Samples were solved in mobile phase up to the target concentration, filtered and directly injected. The three statins were resolved in 30 min, using an aqueous solution of 0.10 M sodium dodecyl sulfate - 7.0% 1-butanol, buffered at pH 3 with 0.01 M phosphate salt as mobile phase, running under isocratic mode at 1 mL/min through a C18 column...

Family caregivers play an essential role in supporting the health and well-being of older adults with dementia, a population projected to increase rapidly over the coming decades. Enrolling caregivers of people with dementia (PWD) in research studies is vital to generating the evidence necessary to support broader implementation of efficacious intervention programs in real-world care delivery, but a range of challenges impede recruitment and enrollment of sufficiently large and representative sample sizes. In this article, we characterize the challenges and lessons learned from recruiting caregivers of PWD to participate in a pilot randomized control trial...

BACKGROUND/AIMS: The US Department of Veterans Affairs Point of Care Clinical Trial Program conducts studies that utilize informatics infrastructure to integrate clinical trial protocols into routine care delivery. The Diuretic Comparison Project compared hydrochlorothiazide to chlorthalidone in reduction of major cardiovascular events in subjects with hypertension. Here we describe the cultural, technical, regulatory, and logistical challenges and solutions that enabled successful implementation of this large pragmatic comparative effectiveness Point of Care clinical trial...